Preoperative Imaging in Patients with Deep Infiltrating Endometriosis: An Important Aid in Predicting Depth of Infiltration in Rectosigmoid Disease.

STUDY OBJECTIVE: To determine the diagnostic accuracy of specialist-performed transvaginal ultrasound (TVUS) and pelvic magnetic resonance imaging (MRI) modalities in predicting depth of deep infiltrating endometriosis (DIE) of the rectosigmoid by comparison with histologic specimens obtained at surgery. DESIGN: A retrospective analysis, which met the Standards for Reporting of Diagnostic Accuracy Studies (2015) guidelines for a diagnostic accuracy study. SETTING: Tertiary teaching hospital. PATIENTS: A total of 194 cases who underwent preoperative discussion at the gynecologic endosurgery unit multidisciplinary meeting between January 2012 and December 2019 were eligible for inclusion. INTERVENTIONS: Retrospective assessment of the accuracy of TVUS and MRI in predicting histologic depth of rectosigmoid DIE after operative management. MEASUREMENTS AND MAIN RESULTS: Al total of 135 surgeries were performed for DIE; 20 underwent a rectal shave, 14 had a disc/wedge resection, 38 an anterior/segmental resection, and 63 had no rectosigmoid surgery. Of the 52 patients with full-thickness rectal wall excision, all patients had at least one imaging modality available for review; 42 (81%) had both. At least one imaging modality was in agreement with histologic depth in 48 cases (92%) (sensitivity, 94%; specificity, 50%; positive predictive value [PPV], 97.9%; negative predictive value [NPV], 25.0%; area under the receiver operating curve, 0.720; 95% confidence interval, 0.229-1.000). When TVUS was assessed in isolation, the test remained sensitive for any rectal wall involvement (sensitivity, 93.6%; specificity, 50.0%; PPV, 97.8%; NPV, 25.0%; area under the receiver operating curve, 0.718; 95% confidence interval, 0.227-1.000). When only MRI was assessed, the test demonstrated both high sensitivity and specificity for rectal wall disease (sensitivity, 86.4%; specificity, 100%; PPV, 100%; NPV, 14.2). CONCLUSION: Specialist-performed TVUS and MRI are accurate in predicting depth of disease in rectosigmoid endometriosis. These modalities were similar in their diagnostic performance at assessing depth of rectal wall involvement, and their use is justified in the preoperative planning of these gynecologic surgeries.

Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial.

BACKGROUND: The optimal dosing strategy for infliximab in steroid-refractory acute severe ulcerative colitis (ASUC) is unknown. We compared intensified and standard dose infliximab rescue strategies and explored maintenance therapies following infliximab induction in ASUC. METHODS: In this open-label, multicentre, randomised controlled trial, patients aged 18 years or older from 13 Australian tertiary hospitals with intravenous steroid-refractory ASUC were randomly assigned (1:2) to receive a first dose of 10 mg/kg infliximab or 5 mg/kg infliximab (randomisation 1). Block randomisation was used and stratified by history of thiopurine exposure and study site, with allocation concealment maintained via computer-generated randomisation. Patients in the 10 mg/kg group (intensified induction strategy [IIS]) received a second dose at day 7 or earlier at the time of non-response; all patients in the 5 mg/kg group were re-randomised between day 3 and day 7 (1:1; randomisation 2) to a standard induction strategy (SIS) or accelerated induction strategy (AIS), resulting in three induction groups. Patients in the SIS group received 5 mg/kg infliximab at weeks 0, 2, and 6, with an extra 5 mg/kg dose between day 3 and day 7 if no response. Patients in the AIS group received 5 mg/kg infliximab at weeks 0, 1, and 3, with the week 1 dose increased to 10 mg/kg and given between day 3 and day 7 if no response. The primary outcome was clinical response by day 7 (reduction in Lichtiger score to <10 with a decrease of ≥3 points from baseline, improvement in rectal bleeding, and decreased stool frequency to ≤4 per day). Secondary endpoints assessed outcomes to day 7 and exploratory outcomes compared induction regimens until month 3. From month 3, maintenance therapy was selected based on treatment experience, with use of thiopurine monotherapy, combination infliximab and thiopurine, or infliximab monotherapy, with follow-up as a cohort study up to month 12. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02770040, and is completed. FINDINGS: Between July 20, 2016, and Sept 24, 2021, 138 patients were randomly assigned (63 [46%] female and 75 [54%] male); 46 received a first dose of 10 mg/kg infliximab and 92 received 5 mg/kg infliximab. After randomisation 1, we observed no significant difference in the proportion of patients who had a clinical response by day 7 between the 10 mg/kg and 5 mg/kg groups (30 [65%] of 46 vs 56 [61%] of 92, p=0·62; risk ratio adjusted for thiopurine treatment history, 1·06 [95% CI 0·94-1·20], p=0·32). We found no significant differences in secondary endpoints including time to clinical response or change in Lichtiger score from baseline to day 7. Two patients who received 10 mg/kg infliximab underwent colectomy in the first 7 days compared with no patients in the 5 mg/kg group (p=0·21). Three serious adverse events occurred in three patients in both the 10 mg/kg group and 5 mg/kg group. After randomisation 2, the proportions of patients with clinical response at day 14 (34 [74%] of 46 in the IIS group, 35 [73%] of 48 in the AIS group, and 30 [68%] of 44 in the SIS group, p=0·81), clinical remission at month 3 (23 [50%], 25 [52%], 21 [48%], p=0·92), steroid-free remission at month 3 (19 [41%], 20 [42%], 18 [41%], p=1·0), endoscopic remission at month 3 (21 [46%], 22 [46%], 21 [48%], p=0·98), and colectomy at month 3 (three [7%] of 45, nine [19%] of 47, five [12%] of 43, p=0·20) were not significantly different between groups. Between day 8 and month 3, the proportion of patients with at least one infectious adverse event possibly related to infliximab was two (4%) of 46 in the IIS group, eight (17%) of 48 in the AIS group, and eight (18%) of 44 in the SIS group (p=0·082). No deaths occurred in the study. INTERPRETATION: Infliximab is a safe and effective rescue therapy in ASUC. In steroid-refractory ASUC, a first dose of 10 mg/kg infliximab was not superior to 5 mg/kg infliximab in achieving clinical response by day 7. Intensified, accelerated, and standard induction regimens did not result in a significant difference in clinical response by day 14 or in remission or colectomy rates by month 3. FUNDING: Australian National Health and Medical Research Council, Gastroenterology Society of Australia, Gandel Philanthropy, Australian Postgraduate Award, Janssen-Cilag.

Prospective Assessment of Tumour Burden and Bone Disease in Plasma Cell Dyscrasias Using DW-MRI and Exploratory Bone Biomarkers.

Novel biomarkers for tumour burden and bone disease are required to guide clinical management of plasma cell dyscrasias. Recently, bone turnover markers (BTMs) and Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) have been explored, although their role in the prospective assessment of multiple myeloma (MM) and monoclonal gammopathy of undetermined significance (MGUS) is unclear. Here, we conducted a pilot observational cohort feasibility study combining serum BTMs and DW-MRI in addition to standard clinical assessment. Fifty-five patients were recruited (14 MGUS, 15 smouldering MM, 14 new MM and 12 relapsed MM) and had DW-MRI and serum biomarkers (P1NP, CTX-1, ALP, DKK1, sclerostin, RANKL:OPG and BCMA) measured at baseline and 6-month follow-up. Serum sclerostin positively correlated with bone mineral density (r = 0.40-0.54). At baseline, serum BCMA correlated with serum paraprotein (r = 0.42) and serum DKK1 correlated with serum free light chains (r = 0.67); the longitudinal change in both biomarkers differed between International Myeloma Working Group (IMWG)-defined responders and non-responders. Myeloma Response Assessment and Diagnosis System (MY-RADS) scoring of serial DW-MRI correlated with conventional IMWG response criteria for measuring longitudinal changes in tumour burden. Overall, our pilot study suggests candidate radiological and serum biomarkers of tumour burden and bone loss in MM/MGUS, which warrant further exploration in larger cohorts to validate the findings and to better understand their clinical utility.

Sacral nerve neuromodulation is effective treatment for fecal incontinence in the presence of a sphincter defect, pudendal neuropathy, or previous sphincter repair.

PURPOSE: To assess the effectiveness of sacral nerve neurostimulation in the setting of sphincter defects, previous sphincter repair, or pudendal neuropathy. METHODS: A total of 55 patients underwent insertion of a sacral nerve neurostimulator for fecal incontinence. There were 52 female and 3 male patients, with a mean age of 51 (range, 25-65) years and a median follow-up of 37 (range, 15-41) months. RESULTS: There was a significant improvement in the median Cleveland Clinic continence score for all of the patients, from a median of 15 (13-18) before insertion of the neurostimulator, to a median of between 4 and 7 during the follow-up period of up to 48 months. (P < .001-.008). Patients with a sphincter defect on endoanal ultrasound, a pudendal neuropathy, or a previous sphincter repair did not show any significant differences in continence scores during the follow-up period (P = .46, .25, and .81, respectively). The Fecal Incontinence Quality of Life score also showed a significant improvement on all 4 scales, Lifestyle (median 2.00 baseline to 3.00-3.70 P = .001-.008), Coping/Behavior (median 1.56 baseline to 2.89-3.22 P = .001-.007), Depression/Self-Perception (median 2.29 baseline to 2.93-3.71 P = .001-.005), and Embarrassment (median 1.50 baseline to 2.17-3.00 P = .001-.013) after insertion at all time intervals up to 36 months. The Fecal Incontinence Quality of Life score was higher than the baseline at 48 months but only statistically significant for Lifestyle (median 3.10, P = .04) and Coping/Behavior (median 2.63, P = .03) scores. There were 6 device-related complications. CONCLUSIONS: Sacral nerve neuromodulation results in a significant improvement in fecal incontinence and Fecal Incontinence Quality of Life scores after medium-term follow-up, even when there is a sphincter defect or pudendal neuropathy.

Brush cytology for the diagnosis of colorectal cancer.

PURPOSE: The purpose of this study was to analyze the results of brush cytology for the diagnosis of colorectal cancer and compare them with the results of endoscopic biopsy and histologic evaluation of the resected specimen. METHODS: Nine hundred eighteen patients who had brush cytology, endoscopic biopsy, and a definitive resection of a colorectal lesion between 1990 to 2006 were identified from our pathology database. RESULTS: Cytology alone had a sensitivity of 88.2 percent, a specificity of 94.1 percent, a positive predictive value of 98.6 percent, and a negative predictive value of 61.9 percent for the diagnosis of colorectal cancer. Brush cytology always recognized malignant cells, with a positive predictive value of 100 percent. There was no significant difference between brush cytology and biopsy, which had a sensitivity of 86.9 percent, specificity of 98.1 percent, positive predictive value of 99.5 percent, and a negative predictive value of 60.3 percent. Combining the results of brush cytology and biopsy resulted in a statistically significant increase in sensitivity to 97.4 percent (P < 0.001), a significant increase in the negative predictive value to 88.4 percent (P < 0.001), and a significant reduction in the false-negative rate to 0.03 percent (P < 0.001) for the diagnosis of colorectal cancer. CONCLUSIONS: Brush cytology is as accurate as endoscopic biopsy for the diagnosis of colorectal cancer, and combining these two diagnostic modalities resulted in a significant improvement in the definitive diagnosis of cancer, which might reduce the need for further biopsy.

Rectal endometriosis: results of radical excision and review of published work.

BACKGROUND: The aim of this paper is to review the results of surgical excision of rectal endometriosis and review the published work on this challenging condition. METHODS: All cases of endometriosis involving the rectum treated by a single colorectal surgeon were identified from a prospective database and the results reviewed. RESULTS: Between 1995 and 2005, 213 rectal procedures were carried out on 203 patients together with an endogynaecologist. Eighteen cases involved dissection of endometriosis off the rectal wall, 58 involved full-thickness excision of the anterior rectal wall and 137 segmental excisions of the rectum were carried out. A loop ileostomy was required in 7 (5%) of the segmental resections. Seventy-five per cent of the cases were either laparoscopic or laparoscopically assisted. Infertility was significantly more common in the group requiring a segmental resection (P=0.026) and a history of rectal pain during defecation more common in patients having dissection of endometriosis off the rectal wall (P=0.031). There were no other significant differences between the different types of rectal surgery. The morbidity for all rectal procedures was 7% and there was one anastomotic leak in the segmental resection group. The actuarial rectal recurrence rate of endometriosis was 22.2% 95% confidence interval (CI) (2.5, 42.0) for dissection off the rectal wall and this was significantly different from the recurrence of 5.17% 95%CI (0.0, 10.9) for anterior rectal wall excision and 2.19% 95%CI (0.0, 4.6) for segmental rectal resection (P=0.007). The overall rectal recurrence for all cases was 4.69% 95%CI (1.8, 7.5). CONCLUSION: Endometriosis of the rectum can be successfully treated with low morbidity and low recurrence rates by excising the disease as completely as possible using full-thickness excision of the anterior rectal wall or segmental resection of the rectum.

Computer-based logbook for surgical registrars.

BACKGROUND: The documentation and monitoring of operative experience is an important component of advanced surgical training. The Royal Australasian College of Surgeons (RACS) monitors the adequacy of training by use of the surgical logbook. The logbook has been a paper-based record that does not permit longitudinal evaluation of the progress of an individual trainee or comparison of different surgical units. METHODS: An electronic logbook has been developed in FileMaker Pro version 5.03 (FileMaker, Santa Clara, California, USA). RESULTS: The electronic logbook has been employed for 1 year and has been used on both Windows and Macintosh platforms without difficulty. Appropriate summaries of the training experience were provided for the RACS at the conclusion of each rotation. CONCLUSIONS: The use of a relational database for logbook purposes provides trainees with a convenient and versatile record of their experience while meeting RACS requirements for documentation of surgical experience.

Improvement of respiratory symptoms following laparoscopic Nissen fundoplication.

BACKGROUND: Laparoscopic fundoplication has become the standard of care for the management of symptomatic gastro-oesophageal reflux disease (GORD). Although atypical and respiratory symptoms are frequently described in standard texts in association with reflux, the response of respiratory symptoms to management of GORD has not been extensively studied. METHODS: Herein is reported a prospective series of 29 patients who presented with predominantly respiratory symptoms. Typical and respiratory symptoms were graded according to a standard scale. All patients had preoperative investigations confirming GORD. These patients were treated by a laparoscopic Nissen fundoplication and followed up for a minimum of 14 months (range: 14-48 months). Patients were contacted and interviewed by an independent observer. RESULTS: Conversion to open surgery was necessary in three patients. There were four significant complications. Ultimately control of typical reflux symptoms was achieved in 88%. Cough was completely relieved in 81% and improved in a further 13%. Wheeze and nocturnal bronchospasm was completely relieved in 50% and improved in the balance. Dysphagia remains a significant problem, with only 42% of patients completely free of trouble. CONCLUSIONS: Overall the respiratory symptoms were improved in the majority of patients, with cough responding somewhat better than wheeze. Appropriate patient selection remains the greatest challenge when a patient with cough or wheeze that is considered to be due to GORD is referred for surgery.